Safety and Efficacy of Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Osteoarthritis Pain

Condition(s) targeted: Osteoarthritis

Intervention: Buprenorphine transdermal delivery system (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Purdue Pharma LP

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.

Official title: Randomized, Double-Blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Average pain over the last 24 hours score at Weeks 4, 8, and 12.

Secondary outcome: Average pain and worst pain scores, supplemental analgesic medication use.

Detailed description: Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by

radiographic evidence within the last 2 years.

- Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.

Exclusion Criteria:

- Not currently taking and tolerating opioids.

- Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days

of enrollment.

- Requiring frequent analgesic therapy for chronic condition(s), in addition to

osteoarthritis.

Other protocol-specific exclusion/inclusion criteria may apply.

Parkway Medical Center, Birmingham, Alabama 35215, United States

Torrance Clinical Research, Torrance, California 90505, United States

International Clinical Research Network, Chula Vista, California 91910, United States

Accelovance, San Diego, California 92108, United States

Clinical Trials Research, Roseville, California 95661, United States

Southern Colorado Clinic, Pueblo, Colorado 81008, United States

Palm Beach Research Center, West Palm Beach, Florida 33409, United States

Drug Study Institute, Jupiter, Florida 33458, United States

Peninsula Research, Inc., Ormond Beach, Florida 32174, United States

Innovative Research of West Florida, Inc., Largo, Florida 33770, United States

International Medical Research, Ormond Beach, Florida 32174, United States

Georgia Medical Research Institute, Marietta, Georgia 30060, United States

Non- Surgical Orthopedic & Spine Center, P.C., Marietta, Georgia 30060, United States

The Arthritis Center, Springfield, Illinois 62704, United States

Commonwealth Biomedical Research, LLC, Madisonville, Kentucky 42431, United States

Miray Medical Center, Brockton, Massachusetts 23010, United States

Professional Clinical Research Crystal Lake Health Center, Benzonia, Michigan 49616, United States

Rheumatology PC, Kalamazoo, Michigan 49009, United States

Pharm Quest, Greensboro, North Carolina 27401, United States

The Clinical Trial Center, LLC, Jenkintown, Pennsylvania 19046, United States

Texas Medical Research Associates, San Antonio, Texas 78238, United States

Amarillo Center for Clinical Research, Amarillo, Texas 79124, United States

Med Search Professional Group/Pharmaceutical C-Trials Inc., Hurst, Texas 76054, United States

Starting date: April 2004
Ending date: August 2005
Last updated: April 29, 2006